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Drug

Regorafenib

Approved · EMA
ClassVascular endothelial growth factor receptor inhibitorEmerging researchLate-stage developmentCooling momentum

Also known as Stivarga, Régorafénib, REGORAFENIB ANHYDROUS, Regorafenibum.

6
Research papers
54
Active clinical trials
18
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Targeted therapy for hepatocellular carcinoma.

Research2020-08-11Signal transduction and targeted therapy

Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.

Research2019-11-04Journal of experimental & clinical cancer research : CR

Approval: Stivarga (EMA)

Regulatory2013-08-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Regorafenib
Aliases & brands
StivargaRégorafénibREGORAFENIB ANHYDROUSRegorafenibum
RxNorm CUI
1312397
ChEMBL ID
CHEMBL1946170
ATC codes
L01EX05
UNII
24T2A1DOYB
Primary mechanism
Vascular endothelial growth factor receptor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

18 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORVascular endothelial growth factor receptor inhibitor
INHIBITORVascular endothelial growth factor receptor inhibitor
INHIBITORVascular endothelial growth factor receptor inhibitor
INHIBITORSerine/threonine-protein kinase B-raf inhibitor
INHIBITORStem cell growth factor receptor inhibitor
INHIBITORTyrosine-protein kinase ABL inhibitor
INHIBITORPlatelet-derived growth factor receptor inhibitor
INHIBITORPlatelet-derived growth factor receptor inhibitor
INHIBITORTyrosine-protein kinase receptor RET inhibitor
INHIBITORFibroblast growth factor receptor 1 inhibitor
INHIBITORFibroblast growth factor receptor 2 inhibitor
INHIBITORNerve growth factor receptor Trk-A inhibitor
INHIBITORSerine/threonine-protein kinase RAF inhibitor
INHIBITORMAP kinase p38 beta inhibitor
INHIBITORTyrosine-protein kinase FRK inhibitor
INHIBITORDiscoidin domain-containing receptor 2 inhibitor
INHIBITORTyrosine-protein kinase TIE-2 inhibitor
INHIBITOREphrin type-A receptor 2 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-08-26
Latest approval
2013-08-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-08-26Approval
Approval: Stivarga (EMA)
Indication: Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not consideredShow full indication

Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
195
registered trials across all phases
LATEST COMPLETION 2026
54
Active studies
34
Recruiting
34
Late-stage (III+)
84
Completed
57
Discontinued
PHASE DISTRIBUTIONn = 195
Phase 133Phase 1 / 222Phase 2106Phase 2 / 37Phase 319Phase 43Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20172025
Most influential
Recent papers
Major research themes8
Antibodies, Monoclonal, Humanized2Colorectal Neoplasms2Antineoplastic Agents, Immunological1Antineoplastic Combined Chemotherapy Protocols1Drug Delivery Systems1Microsatellite Instability1Phenylurea Compounds1Quinolines1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • ESMO open1
  • Journal of experimental & clinical cancer research : CR1
  • Lancet (London, England)1
  • Signal transduction and targeted therapy1
Leading researchers
  • Adelberg D1
  • Agulnik M1
  • Akashi K1
  • Ananda S1
  • Attia S1
  • Baba E1
  • Baumhauer A1
  • Bodoky G1
Leading institutions
free-text, unnormalised
  • Taipei Veterans General Hospital2
  • 1 Knight Cancer Institute1
  • 10 Indiana University1
  • 11 Mayo Clinic Rochester1
  • 13 Duke Cancer Institute1
  • 14 Mayo Clinic Jacksonville1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 4 of the same disease areas as Regorafenib in the shared literature.

4 shared diseases3 shared papers

Studied across 5 of the same disease areas as Regorafenib in the shared literature.

5 shared diseases2 shared papers

Studied across 3 of the same disease areas as Regorafenib in the shared literature.

3 shared diseases2 shared papers

Studied across 4 of the same disease areas as Regorafenib in the shared literature.

4 shared diseases1 shared paper

Studied across 3 of the same disease areas as Regorafenib in the shared literature.

3 shared diseases1 shared paper

Studied across 2 of the same disease areas as Regorafenib in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.